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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PLATE; IMPLANT
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STRYKER GMBH UNKNOWN PLATE; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2018
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
 
Event Description
The locking screw was chosen with the fibra plate, and used.It occurred that prevented locking event.Because there might be a problem with the screw, opened a new screw of the same size.However, because could not lock it, it was not used for this screw hole, and the operation ended.
 
Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
Event Description
The locking screw was chosen with the fibra plate, and used.It occurred that prevented locking event.Because there might be a problem with the screw, opened a new screw of the same size.However, because could not lock it, it was not used for this screw hole, and the operation ended.
 
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Brand Name
UNKNOWN PLATE
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8210621
MDR Text Key132071352
Report Number0008031020-2019-00001
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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